. /.   WORLD TRADE  
ORGANIZATION  G/TBT/N/PER/30 
6 December 2010 
 (10-6552) 
Committee on Technical Barriers to Trade Original:   Spanish 
  
 
NOTIFICATION 
 
The following notification is being circ ulated in accordance with Article 10.6. 
 
1. Member to Agreement notifying:   PERU
 
If applicable, name of local government involved (Articles 3.2 and 7.2):  
2. Agency responsible:   Ministerio de Salud (Ministry of Health) 
Name and address (including telephone  and fax numbers, e-mail and website 
addresses, if available) of  agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   Ministerio de 
Comercio Exterior y Turismo, MINCETUR  (Ministry of Foreign Trade and Tourism) 
3. Notified under Article 2.9.2 [X], 2.10.1 [ ], 5.6.2 [ ], 5.7.1 [ ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.  
ICS numbers may be provided in  addition, where applicable):  
Pharmaceutical products:  Medicine, herbal me dicine, dietary products and sweeteners, and 
biological and galenic products (classified under Chapter 30 of the Harmonized System or 
in the Customs Tariff); 
Medical devices (falling within tariff headi ngs 9018, 9019, 9021, 9022 and 9402 of the 
Harmonized System or Customs Tariff); 
Sanitary products:  Cosmetics, domestic hygi ene products and absorbent personal hygiene 
products (falling within the following tariff headings of the Harmonized System or Customs Tariff:  3303, 3304, 3305, 3401, 3402, 4818, 5601, subheading 3808.91.3401, 3402, 3809.91.00, 4818 and 5601). 
5. Title, number of pages and language(s) of the notified document:   Reglamento de 
Establecimientos Farmacéuticos (Regulations on pharmaceutical establishments)  
(72 pages, in Spanish). 
6. Description of content:   The notified text contains 149 articles, eight supplementary, 
transitional and final provisions  and 2 annexes.  It sets forth the technical and sanitary 
requirements for establishments engaged in the manufacture, import, export, storage, 
marketing, distribution, dispensation and sal e of pharmaceutical products, medical devices 
and sanitary products. 
7. Objective and rationale, including the nature of urgent problems where applicable:  
Protection of human health G/TBT/N/PER/30 
Page 2  
 
  8. Relevant documents: 
Ley Nº 29459 - Ley de los Productos Farma céuticos, Dispositivos Médicos y Productos 
Sanitarios  (Law No. 29459:  Law on pharmaceutical  products, medical devices and sanitary 
products) 
9. Proposed date of adoption: 
Proposed date of entry into force:  }180 days following its approval and 
publication in the Official Journal El Peruano  
10. Final date for comments:   20 February 2011 
11. Texts available from:  National enquiry  point [X] or address, telephone and fax 
numbers, e-mail and website addresses,  if available of the other body: 
Websites: http://www.comunidadandina.org/SIRT  
  http://www.mincetur.gob.pe/reglamentostecnicos  
  http://www.digemid.minsa.gob.pe  
 
Ministerio de Comercio Exterior y Turismo - MINCETUR 
Calle Uno Oeste Nº 50, Urb.  Corpac, Lima 27, Perú Tel.: +(51-1) 513-6100, Ext. 8022 Fax: +(51-1) 513-6100, Ext. 8002 E-mail: otc@mincetur.gob.pe
 
Text available online at: 
http://members.wto.org/crnattach ments/2010/tbt/PER/10_4431_00_s.pdf